K903365 is an FDA 510(k) clearance for the KETOREX SANWA STANDARDS. This device is classified as a Nitroprusside, Ketones (urinary, Non-quant.) (Class I - General Controls, product code JIN).
Submitted by Ihara Medics U.S., Inc. (Valencia, US). The FDA issued a Cleared decision on December 20, 1990, 147 days after receiving the submission on July 26, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1435.
| 510(k) Number | K903365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 1990 |
| Decision Date | December 20, 1990 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIN — Nitroprusside, Ketones (urinary, Non-quant.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1435 |